Tylenol

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INDICATIONS

USES

DOSAGE AND ADMINISTRATION

DOSAGE RANGE

a. Administration

TYLENOL (acetaminophen) ® acetaminophen products are only administered orally. They are
available in a variety of convenient dosage forms as listed in Tables 2 and
3. For ease of administration for young children, Infants' TYLENOL (acetaminophen) Concentrated
Drops are more concentrated than the Children's TYLENOL (acetaminophen) liquid formulations.
Infants' TYLENOL (acetaminophen) Concentrated Drops labeling instructs consumers to use only
the dropper enclosed in the carton to dose the product and not to use any other
dosing device with the product, such as spoons, droppers, or cups that come
with other medicines. The labeling on Children's TYLENOL (acetaminophen) liquid formulations
instructs consumers to use only the measuring cup enclosed in the package to
dose the product and not to use any other dosing device, such as kitchen teaspoons,
droppers, or cups that come with other medicines. TYLENOL® (acetaminophen) Arthritis Extended
Relief Caplets should not be crushed, chewed, or dissolved in a liquid.

b. Adult Dosage

For adults and children 12 years of age and older, the recommended dose of
acetaminophen is 650 to 1000 mg every 4 to 6 hours as needed, not to exceed
4000 mg in 24 hours (Table 2). For extended-release acetaminophen, the dose
is 1300 mg every 8 hours as needed, not to exceed 3900 mg in 24 hours. Some
adult products (Extra Strength TYLENOL (acetaminophen) , TYLENOL (acetaminophen) Arthritis Extended Relief Formula)
are not intended for use in children under 12 years of age.

c. Pediatric Dosage

For children under 12 years of age, the recommended dose of acetaminophen is
10 to 15 mg/kg every 4 to 6 hours,47 not to exceed five doses (50-75
mg/kg) in 24 hours (Table 3).

Age-Related Dosing Schedule

The age-related schedule is based on standard age divisions proposed by the
United States Food and Drug Administration (FDA) and used in the development
of an acetaminophen dosing schedule.47

TABLE 4. Recommended pediatric dosing of acetaminophen by
weight and age (adapted from reference 47, with permission)*

Weight

Agea

doseb (mg)

Single Recommended
daily dose (mg)

lb

kg

6-11

2.0 - 5.4

0-3 monthsc

40

200

12 -17

5.5 - 7.9

4-11 months

80

400

18 -23

8.0 - 10.9

12 - 23 months

120

600

24-35

11.0 - 15.9

2-3 years

160

800

36-47

16.0 - 21.9

4-5 years

240

1200

48-59

22.0 -26.9

6-8 years

320

1600

60-71

27.0 - 31.9

9-10 years

400

2000

72-95

32.0 -43.9

11 years

480

2400

* Refer to package label for more specific
information related to dosing. a For adults and children 12 years of age and older see Table
2. b Doses may be repeated every 4 hours but not more than five
times dailyc Data not available to define appropriate adjustments, if
any, needed for the immediate neonatal period. Use of antipyretics in
the immediate neonatal period is extremely limited.

Weight-Related Dosing Schedule

This weight-related dosing schedule was developed and recommended by McNeil
Consumer Healthcare when dosing by weight. The weight-related schedule is based
on weight ranges that are consistent with the use of a standard 80-mg dosage
unit.47 Using this method, the weight-related dosage schedule provides
a dose of 10 to 15 mg/kg body weight for a single dose. The weight-related schedule
most closely approximates this dose, so that when possible, consumers should
be instructed to use weight to calculate dose; otherwise, age may be used (Table
4).

The label for Regular Strength TYLENOL® acetaminophen products recommends
that children 6 to 11 years old take 325 mg every 4 to 6 hours, not to exceed
five doses in 24 hours.

d. Use of Recommended Doses for Longer Than 10 Days

Clinical studies have evaluated the use of acetaminophen in adult patients
with osteoarthritis of the knee at recommended doses of 4000 mg/d for up to
4 weeks.48,49 Williams and colleagues50 evaluated the
use of acetaminophen in doses up to 2600 mg/d for up to 2 years. In these studies,
acetaminophen was well tolerated.

The package label for adult TYLENOL® acetaminophen products instructs adults
not to take TYLENOL (acetaminophen) for pain for more than 10 days or for fever for more than
3 days unless directed by a doctor. The package label for Children's TYLENOL (acetaminophen)
products instructs parents not to administer TYLENOL (acetaminophen) to children for pain for
more than 5 days or for fever for more than 3 days unless directed by a doctor.
As with all over-the-counter (OTC) analgesics, this warning is necessary so
that patients and parents will seek appropriate medical evaluation of their condition if it persists beyond these time periods.

e. Alternate/Concomitant Dosing

Concomitant or alternate dosing with more than one antipyretic agent is not
recommended. There are no studies to support alternate dosing of acetaminophen
and ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs). Studies
have demonstrated that single-dose concurrent administration of aspirin and
acetaminophen produced a more prolonged temperature decrement than when either
antipyretic was given alone.51,52

f. Recommended Storage Conditions

Storage requirements for all TYLENOL® acetaminophen drops, liquids, and
solid formulations are as follows: store at room temperature. It is recommended
that high humidity and excessive heat (ie, ≥ 40°C [104°F]) be avoided
for the gelatin-coated formulations (eg, gelcaps, geltabs). Freezing of the
liquid or suspension formulations should be avoided.

g. Expiration Dating Periods for Commercially Available Products

Under room temperature storage conditions, TYLENOL® acetaminophen solid
formulations are generally stable for 3 years and liquid formulations are generally
stable for 2 years from the date of manufacture. Refer to product package for
specific expiration date.